MAUDE Adverse Event Report: NEOCIS INC. YOMI ROBOTIC ASSISTANT FOR DENTAL IMPLANT PLACEMENT; DENTAL NAVIGATION SYSTEM

Model Number	DRW-1000-00
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
After using the yomi robotic-assisted implant placement device to place dental implants in the site of teeth numbers 3 and 4, i noted in the postoperative radiograph that implant angulation was correct, but that the implants were 2 mm closer to each other than the planned position.This will not present a problem with restoring these implants with crowns because the deviation is not of clinical significance in this particular case, but the 2 mm anterior-posterior deviation would be problem in sites that require more precise positioning, as is often the case.Prior to disengaging the robot's tracker arm, i carefully checked the attachment of the tooth link mechanism to the opposite side of the dental arch and it was secure, which rules out a loose connection.The robot was properly calibrated when neocis checked it.I and my staff had recently been fully trained with use of the robot, and we were careful to observe all proper protocols.We were repeatedly promised "submillimetric accuracy" for dental implant osteotomies prepared with this robotic assistance.This case not only showed failure to achieve submillimetric accuracy, it was a deviation that could have endangered the patient with implants not in the correct positions for restoring.I am left not knowing whether this 2 mm deviation was due to a deficiency of the technology itself, a defective unit, improper calibration, misuse of the unit by me or my staff, improper training, or a combination of the above.This adverse event was accentuated by adverse events with the yomi surgical robot on numerous other patients (which i will describe in separate reports).After using the robot for approximately for 40 cases over two or three months, i concluded that patients were being put at risk by continued use of the robot.I informed neocis that i had stopped using the robot because i was concerned about patient safety.Neocis begrudgingly accepted the unit back, but their attitude seemed one of indifference about my safety concerns, seemingly because sales are good, they "can't make them fast enough", and "this just doesn't happen".I am concerned about patient safety with the yomi robot in cases similar to the ones i was doing, which were primarily single implants, with an occasional two- or three-implant case, using the neocis tooth link system for robot positioning and calibration.I am also concerned about how neocis presented fda contraindications for using the yomi device, which include preexisting crowns, bridges or implants on the opposite side of the arch, or temporomandibular joint problems.A very small percentage of potential implant patients are without any of these preexisting conditions, well under five percent in my experience, so the overwhelming majority of patients treated will have the device used in an off-label capacity.Neocis was not forthcoming with these contraindications prior to delivery of the unit, and i did not see any mention of the contraindications in material i had access to prior to purchase and delivery of the robot.Based on my singular experience with this technology, using it in the way we were trained and closely following all protocols, i question whether this product should be on the market for use in such dental implant cases.Neocis continues to make marketing claims that were not substantiated consistently during our clinical use of the device.We encountered true and acceptable precision in only 50-60% of our yomi implant cases.

• Brand Name: YOMI ROBOTIC ASSISTANT FOR DENTAL IMPLANT PLACEMENT
• Common Device Name: DENTAL NAVIGATION SYSTEM
• Manufacturer (Section D): NEOCIS INC.; miami FL 33137
• MDR Report Key: 16462065
• Report Number: MW5115344
• Device Sequence Number: 6756589
• Product Code: QRY
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 02/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DRW-1000-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/28/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL IMPLANTS.
• Patient Age: 80 YR
• Patient Sex: Male